The present invention generally relates to the delivery of medicaments and agents. More specifically, the present invention relates to the delivery of medicaments and agents using chewable products.
It is of course known to provide agents to individuals for a variety of purposes. These agents can be used to treat diseases and as such are typically referred to as drugs or medicaments. Likewise, the drugs or medicaments can be used for prophylactic purposes. Still, it is known to provide agents to an individual for a variety of nonmedical purposes including enhancing performance or maintaining or initiating alertness.
There are a great variety of such agents. These agents run the gamut from stimulants such as caffeine to drugs such as analgesics, tranquilizers, cardiovascular products, insulin, etc. Some such agents are taken on an as needed basis while other agents must be taken at regular intervals by the individual.
Typically, drugs (medicaments) are administered parenterally or enterally. Of course, parenteral administration is the administration of the drug intravenously directly into the blood stream. Enteral refers to the administration of the drug into the gastrointestinal tract. In either case, the goal of the drug administration is to move the drug from the site of administration towards the systemic circulation.
Except when given intravenously, a drug must traverse several semipermeable cell membranes before reaching general circulation. These membranes act as a biological barrier that inhibits the passage of drug molecules. There are believed to be four processes by which drugs move across a biological barrier: passive diffusion; facilitated diffusion; active transport; and pinocytosis.
Passive diffusion is the transport across the cell membrane wherein the driving force for the movement is the concentration gradient of the solute. In orally administered drugs, this absorption occurs in the small intestines. Facilitated diffusion is believed to be based on a carrier component that combines reversibly with the substrate molecule at the cell membrane exterior. The carrier substrate complex diffuses rapidly across the membrane with release of the substrate at the interior surface. Active transport requires an energy expenditure by the cell and appears to be limited to agents with structural similarities to normal body constituents. These agents are usually absorbed from specific sites in the small intestines. Pinocytosis refers to the engulfing of particulars or fluid by a cell. It is believed to play a minor role in drug transport. Merck Manual, 16th Edition, pp. 2598-2599.
In determining the efficacy of a drug and the effectiveness of the use of a drug to treat a disease, drug absorption is a critical concern. Drug absorption refers to the process of drug movement from the site of administration toward the systemic circulation.
Oral administration of drugs is by far the most common method. When administered orally, drug absorption usually occurs due to the transport of cells across the membranes of the epithelial cells within the gastrointestinal tract. Absorption after oral administration is confounded by numerous factors. These factors include differences down the alimentary canal in: the luminal pH; surface area per luminal volume; perfusion of tissue, bile, and mucus flow; and the epithelial membranes. See Merck Manual at page 2599.
A further issue effecting the absorption of orally administered drugs is the form of the drug. Most orally administered drugs are in the form of tablets or capsules. This is primarily for convenience, economy, stability, and patient acceptance. Accordingly, these capsules or tablets must be disintegrated or dissolved in the stomach before absorption can occur. There are a variety of factors capable of varying or retarding disintegration of solid dosage forms. Further, there are a variety of factors that effect the dissolution rate and therefore determine the availability of the drug for absorption. See Merck Manual at page 2600.
Parenteral administration allows for the direct placement of the drug into the blood stream. This usually ensures complete delivery of the dose to the general circulation. However, administration by a route that requires drug transfer through one or more biologic membranes to reach the blood stream precludes a guarantee that all of the drug will eventually be absorbed. Even with parental administration, because capillaries tend to be highly porous, the perfusion (blood flow/gram of tissue) is a major factor in the rate of absorption. Thus, the injection site can markedly influence a drugs"" absorption rate; e.g., the absorption rate of diazepam injected IM into a site with poor blood flow can be much slower than following an oral dose. See Merck Manual at page 2601.
Not only is drug absorption an issue in drug delivery but, the bioavailability of the drug is also critical. Bioavailability is defined as the rate at which and the extent to which the active moiety (drug or metabolite) enters the general circulation, thereby gaining access to the site of action. Bioavailability depends upon a number of factors, including how a drug product is designed and manufactured, its physicochemical properties, and factors that relate to the physiology and pathology of the patient. See Merck Manual at page 2602.
When a drug rapidly dissolves from a drug product and readily passes across membranes, absorption from most site administration tends to be complete. This is not always the case for drugs given orally. Before reaching the vena cava, the drug must move down the alimentary canal and pass through the gut wall and liver, which are common sites of drug metabolism. Thus, the drug may be metabolized before it can be measured in the general circulation. This cause of a decrease in drug input is called the first pass effect. A large number of drugs show low bioavailability owing to an extensive first pass metabolism. The two other most frequent causes of low bioavailability are insufficient time in the GI tract and the presence of competing reactions. See Merck Manual at page 2602.
Bioavailability considerations are most often encountered for orally administered drugs. Differences in bioavailability can have profound clinical significance.
Although parenteral administration does provide a method for eliminating a number of the variables that are present with oral administration, parenteral administration is not a preferable route. Typically, parenteral administration requires the use of medical personnel and is just not warranted nor practical for the administration of most agents and drugs, e.g., analgesics. Even when required parenteral administration is not preferred due to patient concerns including comfort, infection, etc., as well as the equipment and costs involved. However, despite best efforts certain therapies require parenterally injected drugs. For example, research for decades has focused on an attempt to deliver insulin to an individual through a non-parental means. Despite such efforts today insulin is still only administered intravenously.
There is therefore a need for an improved method of delivering drugs and agents to an individual.
The present invention provides improved products and methods for delivering a medicament or agent to an individual. Improved formulations including medicaments or agents are also provided by the present invention.
To this end, the present invention provides a product including a medicament comprising a consumable center and a compressible composition including a medicament that is compressed around the consumable center. The medicament may be encapsulated.
The chewable consumable center can be, by way of example and not limitation, a gummi candy, confectionary starch, hard candy, licorice-type candy or tableted excipient such as dextrose, sucrose, or other saccharides, sorbitol, mannitol, iso-malitol, other sugar alcohols, or combinations thereof.
In an embodiment, the product has a disk shape.
In an embodiment, the product has a pellet shape.
In an embodiment, the product has a spherical shape.
In an embodiment, the product has a cube shape.
In an embodiment, the encapsulated medicament is encapsulated with a composition selected from the group consisting of: natural polymers; synthetic polymers; modified cellulosics; and protein.
In an embodiment, the consumable center has the same shape as the product.
In an embodiment, the medicament is selected from the group consisting of: analgesics; muscle relaxants; antacids; antihistamines; decongestants; anti-inflammatories; antibiotics; anti-virals; psycotherapeutic agents; hormones; cardiovascular agents; vitamins; minerals; and nutriceuticals.
In an embodiment, the compressible composition includes a masking agent.
In an embodiment, the consumable center is chosen from the group consisting of gummi candy, hard candy, confectionary starch, or compressible excipient.
In another embodiment of the present invention, a composition including a medicament is provided comprising a consumable center and a compressible formulation including a medicament that surrounds the entire consumable center.
In an embodiment, the medicament is encapsulated. To this end, the medicament can be encapsulated with a composition selected from the group consisting of: natural polymers; synthetic polymers; modified cellulosics; and protein.
In an embodiment, the medicament is selected from the group consisting of: analgesics; muscle relaxants; antacids; antihistamines; decongestants; anti-inflammatories; antibiotics; anti-virals; psycotherapeutic agents; hormones; cardiovascular agents; vitamins; minerals; and nutriceuticals.
In a further embodiment of the present invention, an acetominophen containing product is provided comprising a consumable center and a compressible composition including encapsulated acetaminophen, the compressible composition is compressed around the consumable center.
In yet another embodiment of the present invention a method of delivering a medicament is provided comprising the steps of: providing a consumable center; compressing around the consumable center a composition including a medicament; and causing an individual in need of the medicament to chew the product.
In an embodiment, the medicament is encapsulated.
In an embodiment, the medicament is selected from the group consisting of: analgesics; muscle relaxants; antacids; antihistamines; decongestants; anti-inflammatories; antibiotics; anti-virals; psycotherapeutic agents; hormones; cardiovascular agents; vitamins; minerals; and nutriceuticals.
Still further, in an embodiment, the present invention provides a method for providing a medicament comprising the steps of: providing a consumable center; and compressing around the chewing gum center a composition including a medicament.
Additionally, the present invention provides a method of producing a medicament containing product comprising the steps of: producing a consumable center; and surrounding the consumable center with a powder that includes a medicament.
Accordingly, an advantage of the present invention is to provide new methods for delivering medicaments to an individual.
Furthermore, an advantage of the present invention is to provide improved products containing a medicament.
Still further, an advantage of the present invention is to provide a method of delivering medicaments to an individual that provides for increase absorption and bioavailability as compared to medicaments that are designed to be absorbed in the GI tract.
Another advantage of the present invention is to provide a novel method of delivering medicaments to an individual that provide relief from pain symptoms.
Further, an advantage of the present invention is to provide chewable products containing medicaments that have excellent content uniformity.
Still, an advantage of the present invention is to provide a method of delivering medicaments that does not require the individual to take water.
Moreover, an advantage of the present invention is to provide a method for administering medicaments to an individual that heretofore were administered parentally.
Additionally, an advantage of the present invention is to provide a method for administering medicaments that is more palatable than current methods.
Another advantage of the present invention is to provide an improved method for drug delivery.
An additional advantage of the present invention is that it can provide an acetaminophen containing product that can be chewed and is palatable.
Further, an advantage of the present invention is that a chewable product including medicament is provided that can have a variety of shapes.
Additional features and advantages of the present invention will be described in and apparent from the detailed description of the invention and the figures.